Hemiplegia and HemiparesisNCT03282422
Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy
A study testing Home-based protocol in specific tasks and Upper-limb splint in people with Hemiplegia and Hemiparesis and Cerebral Palsy Infantile, run by Universidad San Jorge at 2 sites in Spain.
Trial summary
The main objective: To determine the effectiveness of a treatment that combines the application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy versus a home-based program of specific tasks in improving structure and function, activity… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Hemiplegia and Hemiparesis, Cerebral Palsy Infantile
- What is being tested?
- Home-based protocol in specific tasks and Upper-limb splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesSpain
- Study dates
- 11 Sep 2017to 19 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of unilateral cerebral palsy (hemiplegia-hemiparesis).
- Ages between 5 and 12 years.
- Levels I-III of the Manual Ability Classification System (MACS)
- Levels I-III of the Gross Motor Function Classification System (GMFCS)
- Able to understand and respond to verbal instructions.
Who cannot join
- Cognitive impairment identified by the school report.
- Hand orthopedic surgery in the last 6 months.
- Neuropharmacological intervention in the last 6 months.
- Allergy to upper limb orthosis material.
- Affectation of the manual function not due to the neurological condition (trauma, burn ...).
- Current treatments not compatible with the study.
- Other significant neurological affections (crisis, severe visual impairment ...).
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
AIDIMO Asociación para la investigación en la discapacidad motriz
Zaragoza, 50011
Universidad San Jorge
Zaragoza, 50830
About this study
Official title: Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy. Randomized Clinical Trial
The main objective:
To determine the effectiveness of a treatment that combines the application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy versus a home-based program of specific tasks in improving structure and function, activity and participation.
Hypothesis:
The application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy results in a greater improvement in structure and function, activity and participation compared to the implementation of a home-based specific task program.
Read the detailed description
Randomized clinical trial with blinding of the evaluator and the person analyzing the data.
A home-based protocol of specific tasks will be performed in both groups and one of the groups will also receive a treatment with upper limb splinting. The assessment will be made by a single evaluator with 10 years of experience in the treatment of children with motor disabilities.
- Being tested
- Home-based protocol in specific tasks, Upper-limb splint
- Keywords
- Cerebral palsy, Hemiplegia, Upper-limb splint, Home-based, Social Participation
- Medical subject headings
- Hemiplegia, Paresis, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based protocol in specific tasksDevice
The home-based protocol in specific tasks will be an individualized protocol designed for the child according to the results of the baseline assessment and will require active participation. It is a program that is integrated into the daily routines of the child. A study investigator will tell the family the procedure to follow.
Upper-limb splintDevice
In the case that treatment with splint is also received, a researcher of this study will take measurements of the hand and will provide the appropriate splint. The intensity of the application will be 5 days a week from monday to friday, for 6 hours a day, for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Upper-limb splint and home-based protocol in specific tasks Receives: Device: Home-based protocol in specific tasks; Device: Upper-limb splint |
| Control group | Active comparator | Home-based protocol in specific tasks Receives: Device: Home-based protocol in specific tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
Activity measurement: Assisting Hand Assessment. Measurement of bimanual performance in pre-established tasks. It quantifies the effectiveness with which the child uses his affected hand in bimanual activities.
Measured: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.
Participation and activity measurement: Children's Hand-use Experience Questionnaire. The objective of the questionnaire is to measure bimanual performance in activities of daily living.
Measured: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary outcomes (5)
Secondary Outcome_Change from baseline Box and Blocks Test measure. Measurement of unilateral gross manual dexterity.
Activity measurement: Box and Blocks Test assesses unilateral gross manual dexterity.
Measured: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_2. Change from baseline Jebsen Hand Function Test measure. Measurement of a broad range of uni-manual hand functions required for activities of daily living.
Participation measurement: Jebsen Hand Function Test. The objective of this test is to assess a broad range of uni-manual hand functions required for activities of daily living.7 activities performed with the affected hand and healthy hand separately.
Measured: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_3. Change from baseline House Thumb in Palm Deformity Classification. Classify the deformity level of thumb.
Structure and function measurement: House Thumb in Palm Deformity Classification. This tool classify the deformity levels taking into account the structure of the thumb.
Measured: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_4. Change from baseline Neurological Hand Deformity Classification. This tool classify the deformity levels of wrist and fingers.
Structure and function measurement: Neurological Hand Deformity Classification. This tools classify the deformity levels taking into account the wrist, fingers.
Measured: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_5. Change from baseline Grip and Pinch Strength measure. Measurement of pinch, wrist and foream strength.
Structure and function measurement: Grip and Pinch Strength. One will be used to Assess the grip of the thumb (Pinch Gauge Dynamometer) and another to assess the strength of the wrist and forearm (Hand and Wrist Dynamometer).
Measured: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start11 Sep 2017
- Primary completion28 Feb 2019
- Study completion19 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Hemiplegia and HemiparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- AIDIMO Asociación para la investigación en la discapacidad motriz
- Responsible party
- Sponsor
- Investigators
- María Ortiz Lucas, PhD, Study director, Universidad San JorgeVanesa Abuín Porras, PhD, Study director, Universidad Europea de MadridPatricia Roldán Pérez, MSc, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282422
- Sponsor's protocol ID
- FF_TE_01_Versión 3
- Status last verified
- Apr 2019
- First submitted
- 6 Sep 2017
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
PubMed 16108461Steenbergen B, Gordon AM. Activity limitation in hemiplegic cerebral palsy: evidence for disorders in motor planning. Dev Med Child Neurol. 2006 Sep;48(9):780-3. doi: 10.1017/S0012162206001666.
PubMed 16904028Arner M, Eliasson AC, Nicklasson S, Sommerstein K, Hagglund G. Hand function in cerebral palsy. Report of 367 children in a population-based longitudinal health care program. J Hand Surg Am. 2008 Oct;33(8):1337-47. doi: 10.1016/j.jhsa.2008.02.032.
PubMed 18929198Malagon Valdez J. [Cerebral palsy]. Medicina (B Aires). 2007;67(6 Pt 1):586-92. Spanish.
PubMed 18422084Kolb B, Whishaw IQ. Neuropsicología humana: Ed. Médica Panamericana; 2006.
Cioni G, Sales B, Paolicelli PB, Petacchi E, Scusa MF, Canapicchi R. MRI and clinical characteristics of children with hemiplegic cerebral palsy. Neuropediatrics. 1999 Oct;30(5):249-55. doi: 10.1055/s-2007-973499.
PubMed 10598836Robaina-Castellanos GR, Riesgo-Rodriguez S, Robaina-Castellanos MS. [Definition and classification of cerebral palsy: a problem that has already been solved?]. Rev Neurol. 2007 Jul 16-31;45(2):110-7. Spanish.
PubMed 17642051Himmelmann K, Uvebrant P. The panorama of cerebral palsy in Sweden. XI. Changing patterns in the birth-year period 2003-2006. Acta Paediatr. 2014 Jun;103(6):618-24. doi: 10.1111/apa.12614. Epub 2014 Mar 24.
PubMed 24575788Pueyo-Benito R, Vendrell-Gomez P, Bargallo-Alabart N, Mercader-Sobreques JM. [Neuroimaging and cerebral palsy]. Rev Neurol. 2002 Sep 1-15;35(5):463-9. Spanish.
PubMed 12373681Burtner PA, Poole JL, Torres T, Medora AM, Abeyta R, Keene J, Qualls C. Effect of wrist hand splints on grip, pinch, manual dexterity, and muscle activation in children with spastic hemiplegia: a preliminary study. J Hand Ther. 2008 Jan-Mar;21(1):36-42; quiz 43. doi: 10.1197/j.jht.2007.08.018.
PubMed 18215750Koman LA, Gelberman RH, Toby EB, Poehling GG. Cerebral palsy. Management of the upper extremity. Clin Orthop Relat Res. 1990 Apr;(253):62-74.
PubMed 2180605Novak I, Cusick A, Lannin N. Occupational therapy home programs for cerebral palsy: double-blind, randomized, controlled trial. Pediatrics. 2009 Oct;124(4):e606-14. doi: 10.1542/peds.2009-0288. Epub 2009 Sep 21.
PubMed 19770175Elliott C, Reid S, Hamer P, Alderson J, Elliott B. Lycra((R)) arm splints improve movement fluency in children with cerebral palsy. Gait Posture. 2011 Feb;33(2):214-9. doi: 10.1016/j.gaitpost.2010.11.008. Epub 2010 Dec 4.
PubMed 21131201Ozer K, Chesher SP, Scheker LR. Neuromuscular electrical stimulation and dynamic bracing for the management of upper-extremity spasticity in children with cerebral palsy. Dev Med Child Neurol. 2006 Jul;48(7):559-63. doi: 10.1017/S0012162206001186.
PubMed 16780624Morris C. A review of the efficacy of lower-limb orthoses used for cerebral palsy. Dev Med Child Neurol. 2002 Mar;44(3):205-11. doi: 10.1017/s0012162201001943. No abstract available.
PubMed 12005323
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03282422
- Acronym / sponsor ID
- FF_TE_01_Versión 3
- Keywords
- Cerebral palsy, Hemiplegia, Upper-limb splint, Home-based, Social Participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- AIDIMO Asociación para la investigación en la discapacidad motriz
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective:
To determine the effectiveness of a treatment that combines the application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy versus a home-based program of specific tasks in improving structure and function, activity and participation.
Hypothesis:
The application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy results in a greater improvement in structure and function, activity and participation compared to the implementation of a home-based specific task program.
Detailed description
Randomized clinical trial with blinding of the evaluator and the person analyzing the data.
A home-based protocol of specific tasks will be performed in both groups and one of the groups will also receive a treatment with upper limb splinting. The assessment will be made by a single evaluator with 10 years of experience in the treatment of children with motor disabilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Home-based protocol in specific tasks, Device: Upper-limb splintUpper-limb splint and home-based protocol in specific tasks |
| Control group | Active comparator | Device: Home-based protocol in specific tasksHome-based protocol in specific tasks |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of unilateral cerebral palsy (hemiplegia-hemiparesis).
- Ages between 5 and 12 years.
- Levels I-III of the Manual Ability Classification System (MACS)
- Levels I-III of the Gross Motor Function Classification System (GMFCS)
- Able to understand and respond to verbal instructions.
Key exclusion criteria (7 listed)
- Cognitive impairment identified by the school report.
- Hand orthopedic surgery in the last 6 months.
- Neuropharmacological intervention in the last 6 months.
- Allergy to upper limb orthosis material.
- Affectation of the manual function not due to the neurological condition (trauma, burn ...).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based protocol in specific tasksThe home-based protocol in specific tasks will be an individualized protocol designed for the child according to the results of the baseline assessment and will require active participation. It is a program that is integrated into the daily routines of the child. A study investigator will tell the family the procedure to follow. | Device | Control group, Intervention group |
| Upper-limb splintIn the case that treatment with splint is also received, a researcher of this study will take measurements of the hand and will provide the appropriate splint. The intensity of the application will be 5 days a week from monday to friday, for 6 hours a day, for a period of 6 weeks. | Device | Intervention group |
Primary outcome
Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Activity measurement: Assisting Hand Assessment. Measurement of bimanual performance in pre-established tasks. It quantifies the effectiveness with which the child uses his affected hand in bimanual activities.
Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Participation and activity measurement: Children's Hand-use Experience Questionnaire. The objective of the questionnaire is to measure bimanual performance in activities of daily living.
5 secondary outcomes
Secondary Outcome_Change from baseline Box and Blocks Test measure. Measurement of unilateral gross manual dexterity.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_2. Change from baseline Jebsen Hand Function Test measure. Measurement of a broad range of uni-manual hand functions required for activities of daily living.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_3. Change from baseline House Thumb in Palm Deformity Classification. Classify the deformity level of thumb.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_4. Change from baseline Neurological Hand Deformity Classification. This tool classify the deformity levels of wrist and fingers.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_5. Change from baseline Grip and Pinch Strength measure. Measurement of pinch, wrist and foream strength.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Background: PubMed 16108461Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
- Background: PubMed 16904028Steenbergen B, Gordon AM. Activity limitation in hemiplegic cerebral palsy: evidence for disorders in motor planning. Dev Med Child Neurol. 2006 Sep;48(9):780-3. doi: 10.1017/S0012162206001666.
- Background: PubMed 18929198Arner M, Eliasson AC, Nicklasson S, Sommerstein K, Hagglund G. Hand function in cerebral palsy. Report of 367 children in a population-based longitudinal health care program. J Hand Surg Am. 2008 Oct;33(8):1337-47. doi: 10.1016/j.jhsa.2008.02.032.
- Background: PubMed 18422084Malagon Valdez J. [Cerebral palsy]. Medicina (B Aires). 2007;67(6 Pt 1):586-92. Spanish.
- BackgroundKolb B, Whishaw IQ. Neuropsicología humana: Ed. Médica Panamericana; 2006.
- Background: PubMed 10598836Cioni G, Sales B, Paolicelli PB, Petacchi E, Scusa MF, Canapicchi R. MRI and clinical characteristics of children with hemiplegic cerebral palsy. Neuropediatrics. 1999 Oct;30(5):249-55. doi: 10.1055/s-2007-973499.
- Background: PubMed 17642051Robaina-Castellanos GR, Riesgo-Rodriguez S, Robaina-Castellanos MS. [Definition and classification of cerebral palsy: a problem that has already been solved?]. Rev Neurol. 2007 Jul 16-31;45(2):110-7. Spanish.
- Background: PubMed 24575788Himmelmann K, Uvebrant P. The panorama of cerebral palsy in Sweden. XI. Changing patterns in the birth-year period 2003-2006. Acta Paediatr. 2014 Jun;103(6):618-24. doi: 10.1111/apa.12614. Epub 2014 Mar 24.
- Background: PubMed 12373681Pueyo-Benito R, Vendrell-Gomez P, Bargallo-Alabart N, Mercader-Sobreques JM. [Neuroimaging and cerebral palsy]. Rev Neurol. 2002 Sep 1-15;35(5):463-9. Spanish.
- Background: PubMed 18215750Burtner PA, Poole JL, Torres T, Medora AM, Abeyta R, Keene J, Qualls C. Effect of wrist hand splints on grip, pinch, manual dexterity, and muscle activation in children with spastic hemiplegia: a preliminary study. J Hand Ther. 2008 Jan-Mar;21(1):36-42; quiz 43. doi: 10.1197/j.jht.2007.08.018.
- Background: PubMed 2180605Koman LA, Gelberman RH, Toby EB, Poehling GG. Cerebral palsy. Management of the upper extremity. Clin Orthop Relat Res. 1990 Apr;(253):62-74.
- Background: PubMed 19770175Novak I, Cusick A, Lannin N. Occupational therapy home programs for cerebral palsy: double-blind, randomized, controlled trial. Pediatrics. 2009 Oct;124(4):e606-14. doi: 10.1542/peds.2009-0288. Epub 2009 Sep 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Ortiz Lucas, PhD study director
Universidad San Jorge
Vanesa Abuín Porras, PhD study director
Universidad Europea de Madrid
Patricia Roldán Pérez, MSc principal investigator
Universidad San Jorge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based protocol in specific tasks and Upper-limb splint in people with Hemiplegia and Hemiparesis and Cerebral Palsy Infantile, run by Universidad San Jorge at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks (time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282422, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.